conference patient report outcome in hematology

What are Patient-Reported Outcome Measures in adequate and well-controlled trials?

Patient-reported Outcome Measures Measures in adequate and well- controlled trials: • Clear statement of objectives • Distinguish effect of the drug from other influences • Well-defined and reliable assessments Reference 21 CFR 314.126, 21 CFR 201.57(c)(7)

Are Patient-Reported Outcomes of a clinical intervention important?

The outcomes of a clinical intervention obtained by the patient i.e. patient-reported outcomes (PROs) are seemed to be of more importance in future than any other outcomes like clinical, physiological or caregiver-reported.

What is the food and Drug Administration Guidance on Patient Reported Outcomes?

U.S Department of Health and Human Services Food and Drug Administration Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [Last Accessed on2011 Apr 20];U.S. FDA, Clinical/Medical.

What are patient-reported outcome measure?

Patient-reported outcome measures (PROMs) are used to assess a patient's health status at a particular point in time. PROMs tools can be completed either during an illness or while treating a health condition. In some cases, using pre- and post-event PROMs can help measure the impact of an intervention.

What are patient-reported outcomes in clinical trials?

Patient-reported outcomes (PROs) are any report of the patients' perspectives about the impact of disease and treatment on their health status, for example quality of life and symptoms, without the interpretation of a clinician, or anyone else [1, 2].

How do you collect patient-reported outcomes?

Strategies for Collecting High-Quality Patient-Reported OutcomesSet Clear Goals. ... Use Validated Questions When Possible. ... Avoid Multiple Interpretations of Questions. ... Keep It Short and Sweet. ... Ensure Patient Understanding. ... Choose the Best Method for the Target Population. ... Protect a Patient's Right to Refuse. ... Conclusion.

What is patient-reported outcome data?

A patient-reported outcome (PRO) is "an outcome measure based on a report that comes directly from the patient (e.g., study subject) about the status of the patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else,” according to the National Health Council. ...

Why patient reported outcomes are important?

Patient-reported outcomes provide information on the patient experience and can be the target of therapeutic intervention.

What are patient related outcomes?

Patient-Reported Outcomes (PROs) are defined by the National Quality Forum as “any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.” Most healthcare organizations consistently measure things like ...

What is an example of a patient-reported outcome?

Health-Related Quality of Life Numerous generic health status measures, such as the Medical Outcomes Study Short Form SF-36 (and related measures) and the Sickness Impact Profile are classic examples.

What are examples of patient outcomes?

Results. The attributes of patient outcomes include (1) patient functional status (maintained or improved), (2) patient safety (protected or unharmed), and (3) patient satisfaction (patient reporting of comfort and contentment).

What are two types of patient-reported outcome measures?

There are two basic types: General health PROMs can be used to survey patients with any condition. They usually focus on general well-being, mental health and/or quality of life. Condition-specific PROMs usually concentrate on the symptoms of a particular disease.

Abstract

Patient-reported outcome (PRO) measurement plays an increasingly important role in health care and understanding health outcomes. PROs are any report of a patient's health status that comes directly from the patient, and can measure patient symptoms, patient function, and quality-of-life.

Patient-reported outcome measures

Patient-reported outcome (PRO) measurement plays an increasingly important role in health care and understanding health outcomes. PROs are any report of a patient's health status that comes directly from the patient.

PROs systematically quantify patient experiences

Adults and children with cancer commonly experience symptoms that lead to impaired physical function, emotional function, and social function resulting in decreased health status. 3-7 Patient symptoms often go undetected during typical clinic interviews, and clinicians may underestimate the impact of symptoms from interview alone.

PRO use in clinical practice is feasible and beneficial

PRO measures are recognized tools that can be used to assess impairment in a clinical setting. 9, 18-21 Multiple studies confirm that clinical integration of PROs does not increase the duration of clinic visits, that provider and patient satisfaction is high, and that all parties feel their use improves communication. 12, 19, 20, 22-24

PRO use improves physician patient communication

Several randomized trials have examined the impact of clinical use of PROs on patient–physician communication in adult oncology patients. In these studies, providers were randomized to receive PRO data compared with control groups who did not receive PRO data prior to clinic visits.

Electronic data collection and use within electronic medical records (EMRs)

Use of EMRs in the United States is required for public and private healthcare providers to maintain Medicaid and Medicare reimbursement. Integration of PROs into EMR is a vital step toward improving accessibility and user-friendliness of PROs in clinical and research settings.

PROs Can be used to tailor supportive care for individuals

The ultimate goal of health care is to restore or preserve functioning and well-being related to health. 30 Achieving this goal in hematology/oncology care is challenging because many distressing symptoms are subjective in nature.

BACKGROUND AND AIMS

Patients with haematological malignancies (HM) may experience significantly compromised quality of life (QoL) as a result of the disease and its treatments. 1-4 It is paramount to seek and capture patients’ unmet needs in routine clinical practice.

METHODS

Patients aged ≥ 18 years old with different HM completed the Russian version of the HM-PRO before seeing the haematologist in out- or inpatient settings. Haematologists then reviewed patients’ responses during the consultation, as well as completed clinical and demographic information.

RESULTS

Physicians reported that the HM-PRO was useful for patient management in 155 cases (81%), which included all stages: at diagnosis, during treatment, and at follow-up.

CONCLUSION

The authors demonstrated that the newly developed PRO measure for HM is an informative tool to identify the impact of the disease and its treatment on patients’ QoL as well as S&S in this patient population in routine haematological practice.